Ashley Preston Email and Phone Number
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As the SVP of Global Regulatory Affairs, Quality & Operational Excellence at Syros Pharmaceuticals, I leverage my 20+ years of drug development and regulatory affairs experience to build and lead high-performing teams that drive and execute global development strategies for innovative medicines. I am also a RAC US certified professional who has a deep understanding of the US regulatory landscape and requirements.In my current role, I oversee all regulatory affairs, quality assurance, and medical writing activities across multiple clinical-stage assets, ensuring high-quality, submission-ready content and GXP compliance throughout Syros' drug development operations. I also spearhead Operational Excellence workstreams to integrate ideas, provide innovative solutions, and develop best practices for the organization, to efficiently scale up while maintaining a nimble governance structure. I am passionate about advancing science and improving patient outcomes through regulatory excellence and quality compliance.
Blossomhill Therapeutics, Inc.
View- Website:
- bhtherapeutics.com
- Employees:
- 52
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Svp Global Regulatory Affairs And Quality AssuranceBlossomhill Therapeutics, Inc.Boston, Ma, Us
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Svp Global Regulatory Affairs, Quality & Operational ExcellenceSyros Pharmaceuticals Feb 2021 - PresentCambridge , Ma, Us- Building and leading the Global Regulatory Affairs and Quality Assurance organization at Syros, with responsibility for all Regulatory Affairs, Quality Assurance and Medical Writing activities to support multiple clinical-stage assets.- Leading the Regulatory team to design and execute Global Regulatory Strategies for the pipeline molecules throughout their development life cycle.- Leading the Quality team to actively promote a Quality Compliance Culture, and to ensure GXP compliance throughout Syros’ drug development operations.- Leading the Medical Writing team to deliver high-quality, submission-ready content for all regulatory submissions.- Building and leading Operational Excellence within the Clinical/Medical organization at Syros, optimizing the effectiveness of the organization to deliver on the development pipeline and the long-term strategic plan. - Leading Operational Excellence workstreams to integrate ideas, provide innovative solutions, and develop best practices for the Clinical/Medical organization, to efficiently scale up with a growing development pipeline, while operating effectively. - As a member of the Syros Extended Management Team, drive the strategic direction and operational effectiveness of the organization. -
Vp Global Regulatory Affairs & Quality AssuranceSyros Pharmaceuticals Jul 2019 - Feb 2021Cambridge , Ma, Us
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Vp Global Regulatory AffairsSyros Pharmaceuticals Oct 2018 - Jul 2019Cambridge , Ma, Us
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Executive Director, Head Of Global Regulatory AffairsH3 Biomedicine Jan 2018 - Oct 2018- Establishing and leading the Global Regulatory Affairs (GRA) function at H3 Biomedicine, with responsibility for the design and execution of Global Regulatory Strategies for the clinical development portfolio, including three clinical stage assets and multiple pre-clinical/discovery programs.- As a member of the Clinical Development Leadership Team (CLDT), driving the strategic direction and operational effectiveness of the Clinical Development Programs.
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Head Of Global Regulatory Science, Process, Compliance & Training (Respct)Emd Serono, Inc. Nov 2015 - Dec 2017Boston, Massachusetts, Us- Leading a new Global Regulatory Affairs (GRA) function, and a new global team, with responsibility for Regulatory Science, Process, Compliance & Training, and a member of the GRA Operations Leadership Team.- Driving the design and execution of the ReSPCT book of work, to: i) promote the institutionalization of Regulatory Science principles and initiatives across GRA; ii) actively manage and continuously improve the GRA quality document landscape; iii) evaluate the GRA compliance status and implement risk mitigation strategies; and iv) actively manage the GRA training matrix and on-boarding program(s). - Leading the creation and implementation of an integrated GRA ‘HealthCheck’ platform, consolidating key data from across the function for assessment of KPIs, compliance and project milestones, enabling informed decision-making for risk mitigation, CAPAs and resource allocation. - Developing and maintaining collaborative internal and external stakeholder relationships, to drive alignment on the implementation of ReSPCT initiatives. -
Head Of International Regulatory & Scientific PolicyMerck Pte Ltd, Singapore, An Affiliate Of Merck Kgaa, Darmstadt, Germany Jun 2013 - Oct 2015Darmstadt, Hessen, De- Leadership and management of all Regulatory & Scientific Policy matters in the International Region (Asia-Pacific, China, Japan, Russia/CIS, Middle-East, Africa).- Engaging with Regulatory Agencies on policy topics relevant to the research, development and commercial activities of Merck Serono.- Actively monitoring the regulatory policy landscape across the International Region to identify, analyse and influence policy changes, thereby maximizing opportunities for, and mitigating risks to, Merck Serono’s development and commercial activities.- Representing Merck Serono on Industry Trade Association committees (PhRMA, EFPIA, IFPMA, etc) for subject matter that is relevant to the interests of International markets, contributing to the development of multiple position papers.- Providing International Regulatory Policy & Intelligence support to the global development teams for the design and execution of global regulatory/development strategies. -
Director Of Regulatory AffairsTakeda Jun 2009 - Jun 2013Tokyo, Jp- Leadership of regulatory activities in the Asia-Pacific region (ex-Japan), and membership of the Takeda Asia-Pacific R&D Leadership Team.- Led the design and implementation of regional regulatory strategies – integrating Asia-Pacific markets into global development program(s) – and driving NDA submissions for multiple products, including: Alogliptin (VIPIDIA), Vonoprazan, Dexlansoprazole, Azilsartan (EDARBI), Brentuximab Vedotin (ADCETRIS), Mifamurtide (MEPACT). - As a member of the Takeda APAC R&D Leadership Team, led negotiations and cross-functional collaborations with global colleagues to ensure alignment on the deliverables for successful product development and registration in Asia-Pacific. Also, I led the regulatory component of negotiations and collaborations with CRO(s) and other consultants.- Recipient of the Takeda Global Award in November 2010 for ‘Establishing the APAC Regional Regulatory Affairs Function and Creating Integrated Regulatory/Development Strategies for Takeda Products in APAC’. - Established the regional regulatory affairs function, including team selection, training and development.- Actively monitored the regional regulatory landscape to identify, assess and act on opportunities and/or mitigate risks to the company development and commercial activities. -
Regulatory Affairs ManagerAvexa Limited Jan 2006 - Jun 2009- Global strategic regulatory planning and submission activities, across three individual projects, including clinical studies in Phases 1, 2 & 3. - Writing, compiling and reviewing global regulatory submissions, including: IND Annual Reports, Type B/C Meeting Briefing Packages, IND Safety Reports, Chemistry Manufacturing & Controls data submissions, Clinical Protocol submissions (Phase 1, 2 & 3), Investigator Brochures, CHMP Scientific Advice Requests, Clinical Trial Applications/IMPD (Phase 3).- Leadership of pivotal interactions, meetings and negotiations with Regulatory Agencies including FDA and EMA.- Leading the regulatory component of negotiations and collaborations with Contract Manufacturer(s), CROs and other external consultants.
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Regulatory Affairs AssociateGlaxosmithkline Australia Pty Ltd Jan 2004 - Jan 2006Brentford, Middlesex, Gb- Registration of new products and maintenance of existing registrations for the Australian and New Zealand markets, across multiple therapeutic areas, including HIV/anti-infective, respiratory, cardiovascular/metabolic and CNS.- Management of interactions and negotiations with TGA and MedSafe.- Contribution to internal projects including creation/maintenance of various SOPs, processes and databases. -
Contract Lecturer In PharmacologyAustralian College Of Sports Therapy Jan 2003 - Aug 2003Melbourne, AuDeveloped, lectured and assessed a single semester Pharmacology course for students studying Myotherapy. -
Assessor/Examiner - CepMedicines Australia 2000 - 2003Deakin, Australian Capital Territory, AuContracted as an Assessor/Examiner for the Medicines Australia Continuing Education Program (CEP), assessing Module 5 'Understanding the Clinical Evidence'.
Ashley Preston Skills
Ashley Preston Education Details
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Rmit UniversityPharmacology -
Monash UniversityPharmacology
Frequently Asked Questions about Ashley Preston
What company does Ashley Preston work for?
Ashley Preston works for Blossomhill Therapeutics, Inc.
What is Ashley Preston's role at the current company?
Ashley Preston's current role is SVP Global Regulatory Affairs and Quality Assurance.
What is Ashley Preston's email address?
Ashley Preston's email address is as****@****eda.com
What is Ashley Preston's direct phone number?
Ashley Preston's direct phone number is +161746*****
What schools did Ashley Preston attend?
Ashley Preston attended Rmit University, Monash University.
What are some of Ashley Preston's interests?
Ashley Preston has interest in Children, Economic Empowerment, Education, Science And Technology, Disaster And Humanitarian Relief, Human Rights, Health.
What skills is Ashley Preston known for?
Ashley Preston has skills like Regulatory Affairs, Regulatory Submissions, Clinical Development, Drug Development, Pharmaceutical Industry, Clinical Trials, Pharmacology, Gmp, Management, Clinical Research, Pharmacovigilance, Regulatory Requirements.
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